Helpful Links

Helpful Links

The following websites and organizations may serve as useful resources for you and your staff.

These helpful links are provided as a public service and are for informational purposes only. No endorsement is made or implied.

American Board of Addiction Medicine

The American Board of Addiction Medicine is the nation’s first medical specialty board that certifies addiction medicine physicians across a range of specialties with the mission to increase access to and to improve the quality of addiction treatment.

American Board of Psychiatry and Neurology

The American Board of Psychiatry and Neurology is a not-for-profit corporation that promotes excellence in practice through certification and maintenance of certification processes, and is a member of the American Board of Medical Specialties.

American Society of Addiction Medicine

The American Society of Addiction Medicine (ASAM), founded in 1954, is a professional medical society representing over 5000 physicians, clinicians, and associated professionals in the field of addiction medicine. ASAM is dedicated to increasing access and improving the quality of addiction treatment, educating physicians and the public, supporting research and prevention, and promoting the appropriate role of physicians in the care of patients with addiction.

National Institute on Drug Abuse

Center for Substance Abuse Treatment (CSAT)

CSAT promotes the quality and availability of community-based substance abuse treatment services for individuals and families who need them. CSAT works with states and community-based groups to improve and expand existing substance abuse treatment services under the Substance Abuse Prevention and Treatment Block Grant Program. CSAT also supports SAMHSA’s free treatment referral service to link people with the community-based substance abuse services they need.

The SAMHSA Buprenorphine Clinical Discussion Web Board

The SAMHSA Buprenorphine Clinical Discussion Web Board is a moderated password-protected Website in which physicians holding waivers from SAMHSA under the authority of the Drug Addiction Treatment Act of 2000 (DATA 2000) can ask and answer clinical questions regarding the use of buprenorphine for the treatment of opioid addiction.

Indication

ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) is indicated for the treatment of opioid dependence. ZUBSOLV should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Treatment should be initiated under the direction of healthcare providers who meet certain qualifying requirements under the Drug Addiction Treatment Act of 2000, and who have been assigned a unique identification number (“X” number).

IMPORTANT SAFETY INFORMATION

Contraindications

ZUBSOLV is contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.

Warnings and Precautions

Addiction, Abuse, and Misuse: Buprenorphine can be abused in a similar manner to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits.

Respiratory Depression: Life-threatening respiratory depression and death have occurred in association with buprenorphine use. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with ZUBSOLV.

Precipitation of Opioid Withdrawal Signs and Symptoms: An opioid withdrawal syndrome is likely to occur with parenteral misuse of ZUBSOLV by individuals physically dependent on full opioid agonists or by sublingual administration before the agonist effects of other opioids have subsided.

Risk of Overdose in Opioid-Naïve Patients: ZUBSOLV is not appropriate as an analgesic. There have been reported deaths of opioid-naïve individuals who received a 2-mg sublingual dose of buprenorphine.

Use in Specific Populations

Lactation: Buprenorphine passes into mother’s milk.

Geriatric Patients: Monitor for sedation and respiratory depression.

Moderate and Severe Hepatic Impairment: Buprenorphine/naloxone products are not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment.

Benzodiazepines: Use caution in prescribing ZUBSOLV for patients receiving benzodiazepines or other CNS depressants and warn patients against concomitant self-administration/misuse.

CYP3A4 Inhibitors and Inducers: Monitor patients starting or ending CYP3A4 inhibitors or inducers for potential over or under dosing.

Antiretrovirals: Patients who are on chronic buprenorphine treatment should have their dose monitored if NNRTIs are added to their treatment regimen. Monitor patients taking buprenorphine and atazanavir with and without ritonavir, and reduce dose of buprenorphine if warranted.

Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue ZUBSOLV if serotonin syndrome is suspected.

This is not a complete list of potential adverse events associated with buprenorphine/naloxone sublingual tablets. Please see full Prescribing Information for a complete list.

To report an adverse event associated with taking ZUBSOLV sublingual tablet, please call 1-888-ZUBSOLV (1-888-982-7658). You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About ZUBSOLV

ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) is indicated for the treatment of opioid dependence. ZUBSOLV should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Treatment should be initiated under the direction of healthcare providers who are certified under the Drug Addiction Treatment Act of 2000, and who have been assigned a unique identification number (“X” number).